Patents for second medical indications and their potential impact on pharmacare in Canada.
Notice bibliographique
Résumé
Introduction The practice of granting patents for second medical indications of known drug compounds is not new in Canada. However, a recent court decision has brought into focus the implications of this practice for pharmacare programs in Canada. In Apotex v. Ontario (Minister of Health), the Superior Court of Ontario upheld a decision by the Ministry of Health and Long-Term Care (hereinafter Health Ontario) to list a generic formulation of sertraline hydrochloride as interchangeable for only one of the brand name drug's three approved indications. The decision by Health Ontario, which was unprecedented in Canada, came following pressure by Pfizer Canada, the maker of the brand name version of sertraline hyrdrochloride called Zo1oft[TM]. While the patent on Zoloft[TM] for treatment of depression had expired, a valid patent remained on Zoloft[TM] for use for other approved indications. The subsisting patent formed the basis for Pfizer's opposition to full interchangeable status for Zoloft[TM]. Although the case is current ly under appeal, it is expected that similar pressure may be brought to bear on other provincial health departments to begin listing drugs in formularies as being only partially interchangeable where one patent on a given drug has expired but others remain in effect. This issue of second medical indication patents and their implications is an important one, as it has the potential to raise costs significantly for already cash-strapped provincial drug programs. It may also have implications for privately funded drug plans, and hence for the cost of private drug insurance programs. At the very least, it may impose costs on provincial health departments to defend themselves in any potential patent infringement actions taken against them. It has also been argued that to list drugs as only partially interchangeable in provincial drug formularies will place difficult burdens on pharmacists and those who prescribe drugs, and may expose them directly to patent infringement liability. This paper considers both the issues raised by the decision in Apotex v. Ontario, and the implications for health departments, doctors and pharmacists. The first part of this paper explores the relevant patent issues. These issues do not receive any direct coverage in Apotex v. Ontario; nevertheless, they underlie the decision in that case. The bar on patenting of medical treatments is considered as well as the means by which drug patents are distinguished from methods of treatment. The legal basis for granting second medical use patents is also assessed. These issues are considered with some comparison to other jurisdictions and in light of Canada's international obligations. The second part of the paper consists of a closer look at Apotex v. Ontario and its implications for provincial pharmacare programs. It includes a consideration of the relevant legislative and regulatory scheme in Ontario, and incorporates a consideration of the various liability issues that may arise for provincial health departments, doctors and pharmacists. I. Patent Issues. A. Methods of Medical Treatment under Patent Law In Canada, methods of medical treatment of humans and animals are not patentable. (2) This is not expressly stated in the Patent Act, (3) but rather has evolved as a matter of interpretation. The leading case on the issue is Tennessee Eastman Co. v. Canada (Commissioner of Patents). (4) In Tennessee Eastman, the Supreme Court of Canada found that the discovery that a known adhesive compound could be used to close wounds was a method of medical treatment, and therefore not patentable. There are policy reasons underlying the exclusion of medical treatments from patentability, as explained by David Vaver: The exception for medical treatment springs from ethical or emotional reasons based on a desire not to hamper the saving of life and the alleviation of suffering. …
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».